RAC Practice Exam – Complete Guide for Regulatory Affairs Certification

The appropriate submission point for a 510(k) premarket notification related to in vitro diagnostic tests is the Center for Devices and Radiological Health (CDRH). This center is part of the FDA and is specifically responsible for regulating medical devices, which include in vitro diagnostic tests. A 510(k) submission demonstrates that the device is safe and effective and is substantially equivalent to a device that is already legally marketed.

The Office of Generic Drugs primarily oversees the approval of generic drugs and is not involved in the regulation of medical devices. The Office of Combination Products deals with products that fall under both drugs and devices or devices and biologics, but that does not include standard in vitro diagnostics, which are distinctly regulated by CDRH. The Center for Biologics Evaluation and Research focuses on biological products, not devices. Thus, the correct route for submitting the application for in vitro diagnostic tests is through the Center for Devices and Radiological Health.